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510(k) Data Aggregation

K Number

K143351

Device Name

iCase Contact Lens Case

Manufacturer

Novabay Pharmaceuticals, Inc

Date Cleared

2015-04-29

(156 days)

Product Code

LRX

Regulation Number

886.5928

Intended Use

For storage of soft (hydrophilic), and rigid gas permeable (RGP) hard contact lenses during disinfection with buffered, saline, 3% hydrogen peroxide contact lens solution. Not to be used with multi-purpose (chemical) disinfection, heat disinfection or saline solutions.

Device Description

The iCase is a personal contact lens case used with one step hydrogen peroxide (H2O2) lens disinfecting/cleaning solutions. The iCase monitors the initial rate of neutralization of hydrogen peroxide (H2O2) and indicates the status of the disinfection cycle using the LED display in the cap. The iCase LED display and monitoring system are disabled after 65 cycles of use to promote routine lens case replacement.

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K Number

K131542

Device Name

NEUTROPHASE(R) SKIN AND WOUND CLEANSER OTC

Manufacturer

Novabay Pharmaceuticals, Inc

Date Cleared

2013-07-24

(56 days)

Product Code

FRO

Regulation Number

N/A

Intended Use

NeutroPhase® Skin and Wound Cleanser OTC is intended for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.

Device Description

NeutroPhase® Skin and Wound Cleanser OTC is a clear, liquid solution cleanser and wound dressing that was previously cleared by FDA for Rx Use only. The device for OTC use is exactly the same as the Rx product. It is composed of hypochlorous acid (HOCI) 0.01% in saline. As a known antimicrobial, it inhibits growth of microorganisms in solution. The cleanser is provided in a glass bottle; a pump attachment for use in spraying the cleanser on wounds is also provided.

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